Published: 31 July 2020

Safety Information

Monitoring

Medsafe emphasises that patients should NOT stop using any medicine or medical device subject to a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your healthcare professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

Rocuronium bromide solution for injection 10mg/mL, Hameln, and reports of lack of efficacy


31 July 2020

Medsafe has received reports of lack of efficacy of Rocuronium bromide solution for injection 10mg/mL, Hameln, batch 11331219A. At this stage the product is not under recall, we are monitoring this situation.

The supplier of this product, Max Health, has performed an initial investigation on the manufacture and distribution of the named batch and there is no evidence as yet to suggest an issue which would impact on the safety, quality or efficacy of this batch. However, Medsafe is requesting details of any further cases of efficacy concerns with this product.

The sponsor has available a reporting form (PDF, 323KB, 3 pages)  to capture relevant clinical information for issues with this medicine. Please report any cases to Medsafe and the company using the Efficacy of Neuromuscular Blocking Drugs Information Collection Form.

Products affected
Additional information
Regulator actions
Reporting

Products affected

Rocuronium bromide solution for injection 10mg/mL, Hameln

Rocuronium bromide solution for injection 10mg/mL, Hameln is approved:

  •  As an adjunct to general anaesthesia to facilitate tracheal intubation during routine induction, and during rapid sequence induction when suxamethonium is contraindicated.
  • As an adjunct in the Intensive Care Unit (ICU) to facilitate intubation and mechanical ventilation.

Additional information

Rocuronium bromide solution for injection 10mg/mL, Hameln is a prescription medicine and is funded by PHARMAC (sole subsidy as of 1 August 2020). PHARMAC is aware of the issue and will continue to work with the supplier to maintain supply.

It’s important to note that the dosage and subsequent response to this medicine is patient specific. The product datasheet contains the following advice in relation to administration:

The dosage of rocuronium bromide should be individualized in each patient. The method of anaesthesia and the expected duration of surgery, the method of sedation and the expected duration of mechanical ventilation, the possible interaction with other medicines that are administered concomitantly and the condition of the patient should be taken into account when determining the dose. The use of an appropriate neuromuscular monitoring technique is recommended for the evaluation of neuromuscular block and recovery.

Regulator actions

Medsafe is continuing to monitor reports of lack of efficacy Rocuronium bromide solution for injection 10mg/mL, Hameln.

Medsafe is investigating the reported issues and is in contact with the New Zealand sponsor.

Reporting

Healthcare professionals are encouraged to report quality issues related to this medicine to Medsafe at recalls@health.govt.nz. Please use the form in the link above.

Healthcare professionals are encouraged to report suspected adverse reactions to medicines to the Centre for Adverse Reactions Monitoring (CARM).

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